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Optimising processes requires not only attention to details but also a strategic vision. It is our claim to develop solutions with you together that help on a short-term and enable acting sustainably on a long-term. When different disciplines go into a common direction a well-rounded solution will be the result. Feasible and pragmatic – tailor-made for your company.

Quality Management & GMP

  • Quality Strategy
  • GMP Compliance & Assessment
  • Management Review
  • Auditing
  • Inspection Preparation

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Drug Regulatory Affairs

  • Licensing Strategy
  • Quality by Design (QbD)
  • Post-Approval Change Management (PACM)
  • Electronic Common Technical Document (eCTD)
  • Technology Transfer
  • Scientific-Technical Documentation
  • Authority Meetings

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Pharma 4.0

  • Pharmaceutical Quality System (PQS)
  • Quality Risk Management (QRM)
  • Knowledge Management (KM)
  • Data Integrity
  • Digital Maturity

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“We cannot direct the wind.
But we can adjust the sails.“

Bertha Calloway

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